Validation & Instructional Guides

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Validation Guide Category Description

Single-Use Bioreactors

Data applicable data to single-use bioreactors that demonstrate their suitability for cell culture applications

Depth Filters

Validation data sets for depth filters to support their suitability for biotechnology and pharmaceuticals applications

Membrane Chromatography

Design, applications, and qualification testing that ensures membrane chromatography devices are suitable for downstream bioprocessing

Palltronic™ Instrumentation

Guidance to achieve and maintain a validated state ensuring process and regulatory requirements are met.

Sterile Connectors/Disconnectors/ Filling Needles

Applicable methodologies and data supporting shelf life studies and suitability for use in biopharmaceutical

Sterilizing Grade Liquid Filters/Air Filters

Comprehensive validation data and information regarding tests conducted to validate the performance of filter cartridges and capsules

Single-Use Storage Biocontainers/Mixers/Powder Bags

Validation data for single-use biocontainers to demonstrate their suitability for biotech and biopharmaceuticals

Tangential Flow Filtration (TFF)

Validation support information containing test data on safety, compatibility, performance, and usage conditions for tangential flow filtration

Virus Filters

Comprehensive validation data to support the qualification and validation of virus retentive filters

Instructional Guide Category Description

Manual

The manual contains all essential information for the user to make full use of the information system.  This manual includes a description of the system functions and capabilities, contingencies and alternate modes of operation.

Instruction for Use (IFU)

Step-by-Step Guide